Around the world, medicinal products are manufactured using different standards called “Good Manufacturing Practices” (GMP). Each country has its own GMPs and its own regulatory agencies.

In the United States, not all ADJUVANTS fall in the category of medicinal products that must comply with GMP standards. For example, the FDA requires that vaccines for human use be manufactured utilizing GMP. However, the FDA does not regulate or oversee vaccines for animals. Veterinary biologics are regulated by the USDA Animal and Plant Health Inspection Service (APHIS), which does not require GMP.